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510(k) Data Aggregation
K Number
K944866Device Name
VIASPAN (BELZER UW - CSS)
Manufacturer
THE DUPONT MERCK PHARMACEUTICAL CO.
Date Cleared
1996-04-22
(567 days)
Product Code
KDL
Regulation Number
876.5880Why did this record match?
Applicant Name (Manufacturer) :
THE DUPONT MERCK PHARMACEUTICAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Belzer UW Cold Storage Solution preserves organs, by cold storage, just as well as currently marketed media, such as Collins' solution. Belzer UW Cold Storage Solution, hereafter known as BELZER UW-CSS, can be used for cold storage of the liver, pancreas, and kidney. BELZER UW-CSS has the potential to be used as a general solution for most organs, both for initial cooling during in situ donor organ flushing and for subsequent cold storage.
Device Description
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